Quality Manager

Quality Manager

Location: Glenview, IL
Salary: $80,000–$90,000 per year
Job Type: Full-time

Position Summary

A manufacturing company specializing in condition-monitoring and product-indicator solutions is seeking a hands-on Quality Manager to lead its Quality Management System (QMS) and ensure compliance with FDA regulations and ISO 13485 standards.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485.
• Lead internal, customer, ISO, and FDA audits.
• Manage CAPA, customer complaints, nonconformances, and root cause analysis.
• Oversee risk assessments and FMEA activities.
• Drive continuous improvement and collaborate with cross-functional teams.

Required Qualifications

• Bachelor's degree in Engineering, Chemistry, Science, Quality, or a related field; equivalent experience may be considered.
• Minimum of 5 years of experience in quality management or a similar role.
• Strong knowledge of ISO 13485, FDA regulations, and quality management systems.
• Hands-on experience with audits, CAPA, and root cause analysis.
• Experience in regulated manufacturing; medical device experience strongly preferred.
• Strong analytical, problem-solving, and leadership skills.

Preferred: Lean/Six Sigma, ERP systems, and QMS software experience. Spanish bilingual skills are a plus.

Compensation & Benefits

• $80,000–$90,000 annual base salary, depending on experience.
• Medical, dental, and vision insurance.
• 401(k), life insurance, and annual bonus.
• Paid holidays and PTO.

Interested candidates are encouraged to apply!

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Life insurance

Education:

• Bachelor's (Preferred)

Experience:

• ISO 13485: 5 years (Preferred)
• FDA regulations applicable to medical devices: 5 years (Preferred)
• Quality management: 5 years (Preferred)

Work Location: In person